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Dynamic Carbon Dioxide (CO2) Administration for Sleep Apnoea

Primary Purpose

Sleep Apnea, Central

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Carbon dioxide
Carbon dioxide
Sponsored by
Imperial College London
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Central focused on measuring Sleep apnea, Periodic breathing, Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women 18 to 79 years of age who have New York Heart Association (NYHA) functional class I through IV heart failure due to ischemic, hypertensive, or idiopathic dilated cardiomyopathy and whose condition had been stabilized by means of optimal medical therapy for at least one month;
  • An LVEF of less than 40% and central sleep apnea, defined as 15 or more episodes of apnea and hypopnea per hour of sleep, more than 50 percent of which are determined to be central rather than obstructive.

Exclusion Criteria:

  • Pregnancy,
  • Myocardial infarction,
  • Unstable angina or cardiac surgery within the previous three months.

Sites / Locations

  • Foundation G. Monasterio
  • Imperial NHS Trust

Outcomes

Primary Outcome Measures

Extent of respiratory instability
Arousals

Secondary Outcome Measures

End-tidal CO2
24 hour urinary catecholamines
Mean heart rate
Number of ectopic heart beats
Mean blood pressure
Mean Ventilation

Full Information

First Posted
January 4, 2010
Last Updated
January 4, 2010
Sponsor
Imperial College London
Collaborators
Imperial College Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01041924
Brief Title
Dynamic Carbon Dioxide (CO2) Administration for Sleep Apnoea
Official Title
Dynamic Carbon Dioxide Administration for Central Sleep Apnoea in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Imperial College London
Collaborators
Imperial College Healthcare NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Normally breathing is controlled by a reflex that responds to the levels of carbon dioxide (CO2) in the blood. In heart failure, where the heart muscle is damaged and therefore does not pump as well, this reflex is exaggerated. The result is a vicious circle: blood CO2 levels fluctuate wildly and as a result breathing also fluctuates with patients hyperventilating at times and briefly stopping breathing at others. During sleep this is called central sleep apnoea (CSA). Patients with CSA wake up throughout the night and whilst some patients are oblivious to this, others are consciously breathless and many patients are tired during the day and feel unable to perform their daily activities. As part of the body's stress response to the erratic pattern of breathing, both blood pressure and heart rate may rise to a level that is harmful in a failing heart, exacerbating the underlying heart failure. Indeed patients who demonstrate this CSA die sooner than those who have heart failure and stable breathing. There are no proven specific therapies for CSA that stabilise breathing, improve sleep quality, and prolong life. We have designed a system which delivers very small doses of CO2, when the blood level of CO2 is predicted to be low. During short daytime recordings, using this system, we have demonstrated that it is possible to stabilise the body's CO2 levels. We aim to test what happens when CO2 is given overnight whilst the patient is sleeping to see whether we can stabilise their breathing over longer durations and whether sleep quality could be improved so that patients are less tired during the day. In addition, we would like to measure whether the stress response is lessened if the breathing is successfully stabilised.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Central
Keywords
Sleep apnea, Periodic breathing, Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Carbon dioxide
Intervention Description
2% inhaled CO2 for up to 8 hours.
Intervention Type
Other
Intervention Name(s)
Carbon dioxide
Intervention Description
Up to a maximum of 2% CO2, only delivered for a maximum of up to 20 seconds per 60 seconds for 8 hours
Primary Outcome Measure Information:
Title
Extent of respiratory instability
Time Frame
over 8 hours
Title
Arousals
Time Frame
over 8 hours
Secondary Outcome Measure Information:
Title
End-tidal CO2
Time Frame
per breath
Title
24 hour urinary catecholamines
Time Frame
per 24 hours
Title
Mean heart rate
Time Frame
per 1 s
Title
Number of ectopic heart beats
Time Frame
per 8 hours
Title
Mean blood pressure
Time Frame
every 9 hours
Title
Mean Ventilation
Time Frame
every 1 second

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women 18 to 79 years of age who have New York Heart Association (NYHA) functional class I through IV heart failure due to ischemic, hypertensive, or idiopathic dilated cardiomyopathy and whose condition had been stabilized by means of optimal medical therapy for at least one month; An LVEF of less than 40% and central sleep apnea, defined as 15 or more episodes of apnea and hypopnea per hour of sleep, more than 50 percent of which are determined to be central rather than obstructive. Exclusion Criteria: Pregnancy, Myocardial infarction, Unstable angina or cardiac surgery within the previous three months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darrel P Francis, MD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foundation G. Monasterio
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Imperial NHS Trust
City
London
ZIP/Postal Code
W21NY
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/19628721?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=2
Description
mathematical modelling work

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Dynamic Carbon Dioxide (CO2) Administration for Sleep Apnoea

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